An Innovative Analytical Platform for Evaluating Vital LNP Characteristics

Nejc Pavlin, Project Manager, Sartorius BIA Separations

Lipid nanoparticles (LNPs) have emerged as versatile drug delivery systems capable of encapsulating various payloads, including different nucleic acids. LNPs offer numerous advantages, such as protection of the payload from degradation, enhanced cellular uptake, and controlled release, making them promising candidates for therapeutic applications. However, the complex composition and structure of LNPs pose significant challenges for their characterization and analysis. In addition to physical properties such as size, polydispersity, surface charge and physical stability, parameters such as encapsulation efficiency, lipid identification and quantification, and the integrity of encapsulated nucleic acids are of great importance. Accurate and reliable analytical methods are essential to ensure the quality, efficacy, and safety of LNPs in various applications. By utilizing liquid chromatography as an analytical tool, researchers and formulation scientists can gain valuable insights into the encapsulation efficiency, lipid composition and quantification, load integrity and size of LNPs loaded with nucleic acids. These analytical methods contribute to the development of robust and efficient lipid-based drug delivery systems, ultimately enhancing the therapeutic outcomes of nucleic acid and protein-based therapies. In this work, we present a robust analytical chromatographic tool, called LNP switcher. It is equipped with two analytical columns of different modalities, independent pumps and multiple detector setup. This configuration enables us to monitor key quality attributes of LNPs production process.

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